Three-day lansoprazole quadruple therapy for Helicobacter pylori-positive duodenal ulcers: a randomized controlled study

Aliment Pharmacol Ther. 2001 Jun;15(6):843-9. doi: 10.1046/j.1365-2036.2001.00999.x.

Abstract

Aim: To compare the efficacy and tolerability of a 3-day quadruple therapy with a standard 7-day triple therapy in eradicating Helicobacter pylori infection and healing duodenal ulcers.

Methods: Patients with H. pylori-positive duodenal ulcers were randomized to receive either lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 400 mg twice daily for 7 days (LCM-7) or lansoprazole 30 mg, clarithromycin 500 mg, metronidazole 400 mg, and bismuth subcitrate 240 mg twice daily for 3 days (LCMB-3). No pre- or post-treatment acid suppression was used. Follow-up endoscopy was performed at week 6.

Results: A total of 118 patients were recruited. Sixty patients in the LCM-7 group and 53 patients in the LCMB-3 group returned for endoscopy. Intention-to-treat eradication rates were 87% and 86% (P=0.94) and per protocol eradication rates were 87% and 94% (P=0.29) in the LCM-7 and LCMB-3 groups, respectively. Per protocol and intention-to-treat ulcer healing rates were 98% and 98% in LCM-7 and 100% and 91% in LCMB-3, respectively. There were no significant differences in efficacy in relation to the initial metronidazole and clarithromycin susceptibility. Significant reduction in the duration of side-effects was found in the LCMB-3 group.

Conclusion: The 3-day quadruple therapy is highly effective, better tolerated and can be considered as a first-line therapy in duodenal ulcer management.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Antacids / administration & dosage
  • Antacids / therapeutic use
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / therapeutic use
  • Anti-Infective Agents / administration & dosage*
  • Anti-Infective Agents / adverse effects
  • Anti-Infective Agents / pharmacology*
  • Clarithromycin / administration & dosage
  • Clarithromycin / therapeutic use
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Duodenal Ulcer / drug therapy*
  • Duodenal Ulcer / microbiology
  • Duodenal Ulcer / pathology
  • Female
  • Humans
  • Lansoprazole
  • Male
  • Metronidazole / administration & dosage
  • Metronidazole / therapeutic use
  • Middle Aged
  • Omeprazole / administration & dosage*
  • Omeprazole / adverse effects
  • Omeprazole / analogs & derivatives*
  • Omeprazole / pharmacology*
  • Organometallic Compounds / therapeutic use
  • Treatment Outcome

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Antacids
  • Anti-Bacterial Agents
  • Anti-Infective Agents
  • Organometallic Compounds
  • Lansoprazole
  • Metronidazole
  • Clarithromycin
  • bismuth tripotassium dicitrate
  • Omeprazole